Family cascade screening for equitable identification of familial hypercholesterolemia: study protocol for a hybrid effectiveness-implementation type III randomized controlled trial.

BACKGROUND: Familial hypercholesterolemia (FH) is a heritable disorder affecting 1.3 million individuals in the USA. Eighty percent of people with FH are undiagnosed, particularly minoritized populations including Black or African American people, Asian or Asian American people, and women across racial groups. Family cascade screening is an evidence-based practice that can increase diagnosis and improve health outcomes but is rarely implemented in routine practice, representing an important care gap. In pilot work, we leveraged best practices from behavioral economics and implementation science-including mixed-methods contextual inquiry with clinicians, patients, and health system constituents-to co-design two patient-facing implementation strategies to address this care gap: (a) an automated health system-mediated strategy and (b) a nonprofit foundation-mediated strategy with contact from a foundation-employed care navigator. This trial will test the comparative effectiveness of these strategies on completion of cascade screening for relatives of individuals with FH, centering equitable reach. METHODS: We will conduct a hybrid effectiveness-implementation type III randomized controlled trial testing the comparative effectiveness of two strategies for implementing cascade screening with 220 individuals with FH (i.e., probands) per arm identified from a large northeastern health system. The primary implementation outcome is reach, or the proportion of probands with at least one first-degree biological relative (parent, sibling, child) in the USA who is screened for FH through the study. Our secondary implementation outcomes include the number of relatives screened and the number of relatives meeting the American Heart Association criteria for FH. Our secondary clinical effectiveness outcome is post-trial proband cholesterol level. We will also use mixed methods to identify implementation strategy mechanisms for implementation strategy effectiveness while centering equity. DISCUSSION: We will test two patient-facing implementation strategies harnessing insights from behavioral economics that were developed collaboratively with constituents. This trial will improve our understanding of how to implement evidence-based cascade screening for FH, which implementation strategies work, for whom, and why. Learnings from this trial can be used to equitably scale cascade screening programs for FH nationally and inform cascade screening implementation efforts for other genetic disorders. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05750667. Registered 15 February 2023-retrospectively registered, https://clinicaltrials.gov/study/NCT05750667 .

Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial.

BACKGROUND: Physical activity is associated with a lower risk of major adverse cardiovascular events, but few individuals achieve guideline recommended levels of physical activity. Strategies informed by behavioral economics increase physical activity, but their longer-term effectiveness is uncertain. We sought to determine the effect of behaviorally-designed gamification, loss-framed financial incentives, or the combination on physical activity compared with attention control over 12-month intervention and 6-month post-intervention follow-up periods. METHODS: Between May 2019 and January 2024, participants with clinical ASCVD or 10-year risk of myocardial infarction, stroke, or cardiovascular death ≥ 7.5% by the pooled cohort equation were enrolled in a pragmatic randomized clinical trial. Participants received a wearable device to track daily steps, established a baseline, selected a step goal increase, and were randomly assigned to control (n = 151), behaviorally-designed gamification (n = 304), loss-framed financial incentives (n = 302), or gamification + financial incentives (n = 305). The trial's primary outcome was change in mean daily steps from baseline through the 12-month intervention period. RESULTS: A total of 1062 patients (mean [SD] age 67 [8], 61% female, 31% non-white) were enrolled. Compared with controls, participants had significantly greater increases in mean daily steps from baseline during the 12-month intervention in the gamification arm (adjusted difference, 538.0; 95% CI, 186.2-889.9; P = 0.0027), financial incentives arm (adjusted difference, 491.8; 95% CI, 139.6-844.1; P = 0.0062), and gamification + financial incentives arm (adjusted difference, 868.0; 95% CI, 516.3-1219.7; P < 0.0001). During 6-month follow-up, physical activity remained significantly greater in the gamification + financial incentives arm than in the control arm (adjusted difference, 576.2; 95% CI, 198.5-954; P = 0.0028) but was not significantly greater in the gamification (adjusted difference, 459.8; 95% CI, 82.0-837.6; P = 0.0171) or financial incentives (adjusted difference, 327.9; 95% CI, -50.2 to 706; P = 0.09) arms, after adjusting for multiple comparisons. CONCLUSIONS: Behaviorally-designed gamification, loss-framed financial incentives, and the combination of both increased physical activity compared with control over a 12-month intervention period, with the largest effect in gamification + financial incentives. These interventions could be a useful component of strategies to reduce cardiovascular risk in high-risk patients.

Qualitative study of perceptions of factors contributing to success or failure among participants in a US weight loss trial of financial incentives and environmental change strategies.

BACKGROUND: The use of financial incentives and environmental change strategies to encourage health behaviour change is increasingly prevalent. However, the experiences of participants in incentive interventions are not well characterised. Examination of participant perceptions of financial incentives and environmental strategies can offer insights about how these interventions are facilitating or failing to encourage behaviour change. OBJECTIVE: This study aimed to learn how participants in a randomised trial that tested financial incentives and environmental interventions to support weight loss perceived factors contributing to their success or failure in the trial. DESIGN: Qualitative study with one-time interviews of trial participants with high and low success in losing weight, supplemented by study records of incentive payments and weight loss. PARTICIPANTS: 24 trial participants (12 with substantial weight loss and 12 with no weight loss) stratified equally across the 4 trial arms (incentives, environmental strategies, combined and usual care) were interviewed. ANALYTICAL APPROACH: Transcribed interviews were coded and interpreted using an iterative process. Explanation development was completed using an abductive approach. RESULTS: Responses of trial participants who were very successful in losing weight differed in several ways from those who were not. Successful participants described more robust prior attempts at dietary and exercise modification, more active engagement with self-limitations, more substantial social support and a greater ability to routinise dietary and exercise changes than did participants who did not lose weight. Successful participants often stated that weight loss was its own reward, even without receiving incentives. Neither group could articulate the details of the incentive intervention or consistently differentiate incentives from study payments. CONCLUSIONS: A number of factors distinguished successful from unsuccessful participants in this intervention. Participants who were successful tended to attribute their success to intrinsic motivation and prior experience. Making incentives more salient may make them more effective for participants with greater extrinsic motivation. TRIAL REGISTRATION NUMBER: NCT02878343.

Quantifying and correcting bias due to outcome dependent self-reported weights in longitudinal study of weight loss interventions.

In response to the escalating global obesity crisis and its associated health and financial burdens, this paper presents a novel methodology for analyzing longitudinal weight loss data and assessing the effectiveness of financial incentives. Drawing from the Keep It Off trial-a three-arm randomized controlled study with 189 participants-we examined the potential impact of financial incentives on weight loss maintenance. Given that some participants choose not to weigh themselves because of small weight change or weight gains, which is a common phenomenon in many weight-loss studies, traditional methods, for example, the Generalized Estimating Equations (GEE) method tends to overestimate the effect size due to the assumption that data are missing completely at random. To address this challenge, we proposed a framework which can identify evidence of missing not at random and conduct bias correction using the estimating equation derived from pairwise composite likelihood. By analyzing the Keep It Off data, we found that the data in this trial are most likely characterized by non-random missingness. Notably, we also found that the enrollment time (i.e., duration time) would be positively associated with the weight loss maintenance after adjusting for the baseline participant characteristics (e.g., age, sex). Moreover, the lottery-based intervention was found to be more effective in weight loss maintenance compared with the direct payment intervention, though the difference was non-statistically significant. This framework's significance extends beyond weight loss research, offering a semi-parametric approach to assess missing data mechanisms and robustly explore associations between exposures (e.g., financial incentives) and key outcomes (e.g., weight loss maintenance). In essence, the proposed methodology provides a powerful toolkit for analyzing real-world longitudinal data, particularly in scenarios with data missing not at random, enriching comprehension of intricate dataset dynamics.

Public Views on Medicaid Work Requirements and Mandatory Premiums in Kentucky.

Importance: Federal and state policymakers continue to pursue work requirements and premiums as conditions of Medicaid participation. Opinion polling should distinguish between general policy preferences and specific views on quotas, penalties, and other elements. Objective: To identify views of adults in Kentucky regarding the design of Medicaid work requirements and premiums. Design, Setting, and Participant: A cross-sectional survey was conducted via telephone and the internet from June 27 through July 11, 2019, of 1203 Kentucky residents 9 months before the state intended to implement Medicaid work requirements and mandatory premiums. Statistical analysis was performed from October 2019 to August 2023. Main Outcomes and Measures: Agreement, disagreement, or neutral views on policy components were the main outcomes. Recruitment for the survey used statewide random-digit dialing and an internet panel to recruit residents aged 18 years or older. Findings were weighted to reflect state demographics. Of 39 110 landlines called, 209 reached an eligible person (of whom 150 participated), 8654 were of unknown eligibility, and 30 247 were ineligible. Of 55 305 cell phone lines called, 617 reached an eligible person (of whom 451 participated), 29 951 were of unknown eligibility, and 24 737 were ineligible. Internet recruitment (602 participants) used a panel of adult Kentucky residents maintained by an external data collector. Results: Percentages were weighted to resemble the adult population of Kentucky residents. Of the participants in the study, 52% (95% CI, 48%-55%) were women, 80% (95% CI, 77%-82%) were younger than 65 years, 41% (95% CI, 38%-45%) were enrolled in Medicaid, 36% (95% CI, 32%-39%) were Republican voters, 32% (95% CI, 29%-36%) were Democratic voters, 14% (95% CI, 11%-16%) were members of racial and ethnic minority groups (including but not limited to American Indian or Alaska Native, Asian, Black, Hispanic or Latinx, and Native Hawaiian or Pacific Islander), and 48% (95% CI, 44%-52%) were employed. Most participants supported work requirements generally (69% [95% CI, 66%-72%]) but did not support terminating benefits due to noncompliance (43% [95% CI, 39%-46%]) or requiring quotas of 20 or more hours per week (34% [95% CI, 31%-38%]). Support for monthly premiums (34% [95% CI, 31%-38%]) and exclusion penalties for premium nonpayment (22% [95% CI, 19%-25%]) was limited. Medicaid enrollees were significantly less supportive of these policies than nonenrollees. For instance, regarding work requirements, agreement was lower (64% [95% CI, 59%-69%] vs 72% [95% CI, 68%-77%]) and disagreement higher (26% [95% CI, 21%-31%] vs 20% [95% CI, 16%-24%]) among current Medicaid enrollees compared with nonenrollees (P = .04). Among Medicaid enrollees, some beliefs about work requirements varied significantly by employment status but not by political affiliation. Among nonenrollees, beliefs about work requirements, premiums, and Medicaid varied significantly by political affiliation but not by employment. Conclusions and Relevance: This study suggests that even when public constituencies express general support for Medicaid work requirements or premiums, they may oppose central design features, such as quotas and termination of benefits. Program participants may also hold significantly different beliefs than nonparticipants, which should be understood before policies are changed.

Qualitative analysis of a remote monitoring intervention for managing heart failure.

BACKGROUND: Heart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology. OBJECTIVE: The goal was to explore patient and clinician perceptions of the program and its impact on perceived health outcomes and better understand why some patients or clinicians did better or worse than others in response to the intervention. APPROACH: This was a retrospective qualitative study utilizing semi-structured interviews with 43 patients and 16 clinicians to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions. KEY RESULTS: Many patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms. CONCLUSION: Our qualitative analysis indicates potential areas for additional exploration and consideration to design better behavioral economic interventions to improve cardiovascular health outcomes for patients with HF. Patients appreciated lottery incentives for adhering to program requirements; however, many were too far along in their disease progression to benefit from the intervention. Clinicians found the amount and frequency of electronic alerts burdensome and felt they did not improve patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02708654.

Food Is Medicine: A Presidential Advisory From the American Heart Association.

Unhealthy diets are a major impediment to achieving a healthier population in the United States. Although there is a relatively clear sense of what constitutes a healthy diet, most of the US population does not eat healthy food at rates consistent with the recommended clinical guidelines. An abundance of barriers, including food and nutrition insecurity, how food is marketed and advertised, access to and affordability of healthy foods, and behavioral challenges such as a focus on immediate versus delayed gratification, stand in the way of healthier dietary patterns for many Americans. Food Is Medicine may be defined as the provision of healthy food resources to prevent, manage, or treat specific clinical conditions in coordination with the health care sector. Although the field has promise, relatively few studies have been conducted with designs that provide strong evidence of associations between Food Is Medicine interventions and health outcomes or health costs. Much work needs to be done to create a stronger body of evidence that convincingly demonstrates the effectiveness and cost-effectiveness of different types of Food Is Medicine interventions. An estimated 90% of the $4.3 trillion annual cost of health care in the United States is spent on medical care for chronic disease. For many of these diseases, diet is a major risk factor, so even modest improvements in diet could have a significant impact. This presidential advisory offers an overview of the state of the field of Food Is Medicine and a road map for a new research initiative that strategically approaches the outstanding questions in the field while prioritizing a human-centered design approach to achieve high rates of patient engagement and sustained behavior change. This will ideally happen in the context of broader efforts to use a health equity-centered approach to enhance the ways in which our food system and related policies support improvements in health.

Philadelphia Beverage Tax and Association With Prices, Purchasing, and Individual-Level Substitution in a National Pharmacy Chain.

Importance: Taxes on sweetened beverages are being implemented around the globe; an understanding of these taxes on individual-level behavior is necessary. Objective: To evaluate the degree to which the sweetened beverage tax in Philadelphia, Pennsylvania, was associated with changes in beverage prices and individual-level purchasing over time at a national pharmacy chain in Philadelphia compared with Baltimore, Maryland. Design, Setting, and Participants: Using a difference-in-differences approach and generalized linear mixed models, this cohort study examined beverage purchases made by loyalty cardholders at a national chain pharmacy retailer with stores in Philadelphia and Baltimore (control city) from before tax to after tax. Beverage sales (in US dollars) were linked by unique loyalty card numbers to enable longitudinal analyses. Data were collected from January 1, 2015, through December 31, 2017 (2 years before tax and 1 year after tax); data analyses were conducted from January through October 2022. Exposure: Implementation of Philadelphia's 1.5 cents/oz tax on sweetened beverages. Main Outcomes and Measures: The outcomes were the change in mean beverage price per-ounce and mean beverage volume purchased per cardholder transaction. Individual-level point-of-sale scanner data from all beverage purchases were analyzed. Results: A total of 1188 unique beverages were purchased from the same stores before tax and after tax. There were 231 065 unique cardholders in Philadelphia and 82 517 in Baltimore. Mean prices of taxed beverages (n = 2 094 220) increased by 1.6 (95% CI, 1.3-2.0) cents/oz (106.7% pass-through) in Philadelphia compared with Baltimore from before tax to after tax. Philadelphia cardholders purchased 7.8% (95% CI -8.1% to -7.5%) fewer ounces of taxed beverages and 1.1% (95% CI, 0.6%-1.7%) more ounces of nontaxed beverages per transaction. Taxed beverages made up a smaller percentage of cardholders' overall beverage purchases after tax (-13.4% [95% CI, -14.2% to -12.6%]), while nontaxed beverages made up a larger share (9.3% [95% CI, 7.7%-10.7%]). Conclusions and Relevance: In this longitudinal cohort study of the Philadelphia beverage tax, the tax was completely passed through to prices and was associated with a 7.8% decline in ounces of taxed beverages purchased at a national pharmacy chain.

Using remotely monitored patient activity patterns after hospital discharge to predict 30 day hospital readmission: a randomized trial.

Hospital readmission prediction models often perform poorly, but most only use information collected until the time of hospital discharge. In this clinical trial, we randomly assigned 500 patients discharged from hospital to home to use either a smartphone or wearable device to collect and transmit remote patient monitoring (RPM) data on activity patterns after hospital discharge. Analyses were conducted at the patient-day level using discrete-time survival analysis. Each arm was split into training and testing folds. The training set used fivefold cross-validation and then final model results are from predictions on the test set. A standard model comprised data collected up to the time of discharge including demographics, comorbidities, hospital length of stay, and vitals prior to discharge. An enhanced model consisted of the standard model plus RPM data. Traditional parametric regression models (logit and lasso) were compared to nonparametric machine learning approaches (random forest, gradient boosting, and ensemble). The main outcome was hospital readmission or death within 30 days of discharge. Prediction of 30-day hospital readmission significantly improved when including remotely-monitored patient data on activity patterns after hospital discharge and using nonparametric machine learning approaches. Wearables slightly outperformed smartphones but both had good prediction of 30-day hospital-readmission.

How Physician Self-Perceptions Affect the Impact of Peer Comparison Feedback on Opioid Prescribing.

Peer comparison feedback is a promising strategy for reducing opioid prescribing and opioid-related harms. Such comparisons may be particularly impactful among underestimating clinicians who do not perceive themselves as high prescribers relative to their peers. But peer comparisons could also unintentionally increase prescribing among overestimating clinicians who do not perceive themselves as lower prescribers than peers. The objective of this study was to assess if the impact of peer comparisons varied by clinicians' preexisting opioid prescribing self-perceptions. Subgroup analysis of a randomized trial of peer comparison interventions among emergency department and urgent care clinicians was used. Generalized mixed-effects models were used to assess whether the impact of peer comparisons, alone or combined with individual feedback, varied by underestimating or overestimating prescriber status. Underestimating and overestimating prescribers were defined as those who self-reported relative prescribing amounts that were lower and higher, respectively, than actual relative baseline amounts. The primary outcome was pills per opioid prescription. Among 438 clinicians, 54% (n = 236) provided baseline prescribing self-perceptions and were included in this analysis. Overall, 17% (n = 40) were underestimating prescribers whereas 5% (n = 11) were overestimating prescribers. Underestimating prescribers exhibited a differentially greater decrease in pills per prescription compared to nonunderestimating clinicians when receiving peer comparison feedback (1.7 pills, 95% CI, -3.2 to -0.2 pills) or combined peer and individual feedback (2.8 pills, 95% CI, -4.8 to -0.8 pills). In contrast, there were no differential changes in pills per prescription for overestimating versus nonoverestimating prescribers after receiving peer comparison (1.5 pills, 95% CI, -0.9 to 3.9 pills) or combined peer and individual feedback (3.0 pills, 95% CI, -0.3 to 6.2 pills). Peer comparisons were more impactful among clinicians who underestimated their prescribing compared to peers. By correcting inaccurate self-perceptions, peer comparison feedback can be an effective strategy for influencing opioid prescribing.

Behavioural economic interventions to embed palliative care in community oncology (BE-EPIC): study protocol for the BE-EPIC randomised controlled trial.

INTRODUCTION: Palliative care (PC) is a medical specialty focusing on providing relief from the symptoms and stress of serious illnesses such as cancer. Early outpatient specialty PC concurrent with cancer-directed treatment improves quality of life and symptom burden, decreases aggressive end-of-life care and is an evidence-based practice endorsed by national guidelines. However, nearly half of patients with advanced cancer do not receive specialty PC prior to dying. The objective of this study is to test the impact of an oncologist-directed default PC referral orders on rates of PC utilisation and patient quality of life. METHODS AND ANALYSIS: This single-centre two-arm pragmatic randomised trial randomises four clinician-led pods, caring for approximately 250 patients who meet guideline-based criteria for PC referral, in a 1:1 fashion into a control or intervention arm. Intervention oncologists receive a nudge consisting of an electronic health record message indicating a patient has a default pended order for PC. Intervention oncologists are given an opportunity to opt out of referral to PC. Oncologists in pods randomised to the control arm will receive no intervention beyond usual practice. The primary outcome is completed PC visits within 12 weeks. Secondary outcomes are change in quality of life and absolute quality of life scores between the two arms. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board at the University of Pennsylvania. Study results will be disseminated in peer-reviewed journals and scientific conferences using methods that describe the results in ways that key stakeholders can best understand and implement. TRIAL REGISTRATION NUMBER: NCT05365997.

A randomized controlled trial of gamification, financial incentives, or both to increase physical activity among patients with elevated risk for cardiovascular disease: rationale and design of the be active study.

BACKGROUND: Higher levels of physical activity are associated with improvements in cardiovascular health, and consensus guidelines recommend that individuals with or at risk for atherosclerotic cardiovascular disease (ASCVD) participate in regular physical activity. However, most adults do not achieve recommended levels of physical activity. Concepts from behavioral economics have been used to design scalable interventions that increase physical activity over short time periods, but the longer-term efficacy of these strategies is uncertain. STUDY DESIGN AND OBJECTIVES: BE ACTIVE (NCT03911141) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of 3 strategies informed by behavioral economic concepts to increase daily physical activity in patients with established ASCVD or 10-year ASCVD risk > 7.5% who are seen in primary care and cardiology clinics affiliated with the University of Pennsylvania Health System. Patients are contacted by email or text message, and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 33% to 50%, and are randomized 1:2:2:2 to control, gamification, financial incentives, or both gamification and financial incentives. Interventions continue for 12 months, with follow-up for an additional 6 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 1050 participants, with a primary endpoint of change from baseline in daily steps over the 12-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 6-month post-intervention follow-up period and change in moderate to vigorous physical activity over the intervention and follow-up periods. If the interventions prove effective, their effects on life expectancy will be compared with their costs in cost-effectiveness analysis. CONCLUSIONS: BE ACTIVE is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification, financial incentives, or both are superior to attention control in increasing physical activity. Its results will have important implications for strategies to promote physical activity in patients with or at risk for ASCVD, as well as for the design and implementation of pragmatic virtual clinical trials within health systems.

Effects of Sugary Beverage Text and Pictorial Warnings: A Randomized Trial.

INTRODUCTION: Multiple U.S. localities have introduced legislation requiring sugar-sweetened beverage (SSB) warnings. This study effects of different warning designs on beverage selections and perceptions. STUDY DESIGN: The study was an RCT. SETTING/PARTICIPANTS: An online virtual convenience store and survey were used with a nationally representative sample of primary caregivers of 6-11-year-olds (n=961). Data were collected in January 2020 and analyzed in May-July 2020. INTERVENTION: Participants were randomized to view SSBs with 1 of 4 front-of-package label designs: (1) no-warning control, (2) health-related text warning, (3) sugar pictorial warning (image of beverage sugar content in cubes/teaspoons/packets with health-related warning text), or (4) health pictorial warning (image of possible health consequences of overconsuming SSBs with health-related warning text). MAIN OUTCOME MEASURES: Outcomes included participants' beverage choice for their child and perceptions of beverages, their assigned labels, and warning policies. RESULTS: Proportionally fewer participants chose a SSB in the sugar pictorial warning condition (-13.4 percentage points; 95% CI= -21.6 to -0.1 percentage points; p=0.007) and in the health pictorial warning condition (-14.7 percentage points; 95% CI= -22.8 to -0.1 percentage points; p=0.004) compared to the control. Sugar pictorial warnings led to more accurate added-sugar content estimates than all conditions and greater label trust and support for sugar-sweetened beverage warning policies than health pictorial warnings. CONCLUSIONS: SSB warning policies may be most effective if they mandate images of beverages' added sugar content accompanied by warning text. TRIAL REGISTRATION: This study is registered at www. CLINICALTRIALS: gov NCT03648138.

Food Allergy Management for Adolescents Using Behavioral Incentives: A Randomized Trial.

OBJECTIVE: We sought to evaluate the use of behavioral economics approaches to promote the carrying of epinephrine auto-injectors (EAIs) among adolescents with food allergies. We hypothesized that adolescents who receive frequent text message nudges (Intervention 1) or frequent text message nudges plus modest financial incentives (Intervention 2) would be more likely to carry their epinephrine than members of the usual care control group. METHODS: We recruited 131 adolescents ages 15 to 19 with a food allergy and a current prescription for epinephrine to participate in a cohort multiple randomized controlled trial. Participants were randomly assigned to participate in Intervention 1, Intervention 2, or to receive usual care. The primary outcome was consistency of epinephrine-carrying, measured as the proportion of checkpoints at which a participant could successfully demonstrate they were carrying their EAI, with photo-documentation of the device. RESULTS: During Intervention 1, participants who received the intervention carried their EAI 28% of the time versus 38% for control group participants (P = .06). During Intervention 2, participations who received the intervention carried their EAI 45% of the time versus 23% for control group participants (P = .002). CONCLUSIONS: Text message nudges alone were unsuccessful at promoting EAI-carrying but text message nudges combined with modest financial incentives almost doubled EAI-carriage rates among those who received the intervention compared with the control group. However, even with the intervention, adolescents with food allergies carried their EAI <50% of the time. Alternative strategies for making EAIs accessible to adolescents at all times should be implemented.

Qualitative Analysis of a Remote Monitoring Intervention for Managing Heart Failure.

Background : Heart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology. Objective : The goal was to explore patient and clinician perceptions of the program and its impact on health outcomes and better understand why some patients/clinicians did better/worse than others in response to the intervention. Approach : This was a retrospective qualitative study to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions. Key Results: Many patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms. Conclusion : Those interviews offer insights into the potential reasons for the study's null result and opportunities for improvements in the future. Trial Registration: ClinicalTrials.gov Identifier: NCT02708654.

Digital Health and Community Health Worker Support for Diabetes Management: a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate the effectiveness of a digital health intervention plus community health worker (CHW) support on self-monitoring of blood glucose and glycosylated hemoglobin (HbA1c) among adult Medicaid beneficiaries with diabetes. DESIGN: Randomized controlled trial. SETTING: Urban outpatient clinic. PARTICIPANTS: Adult Medicaid beneficiaries living with diabetes and treated with insulin and who had a HbA1c ≥ 9%. INTERVENTION: Participants were randomly assigned to one of three arms. Participants in the usual-care arm received a wireless glucometer if needed. Those in the digital arm received a lottery incentive for daily glucose monitoring. Those in the hybrid arm received the lottery plus support from a CHW if they had low adherence or high blood glucose levels. MAIN MEASURES: The primary outcome was the difference in adherence to daily glucose self-monitoring at 3 months between the hybrid and usual-care arms. The secondary outcome was difference in HbA1c from baseline at 6 months. KEY RESULTS: A total of 150 participants were enrolled in the study. A total of 102 participants (68%) completed the study. At 3 months, glucose self-monitoring rates in the hybrid versus usual-care arms were 0.72 vs 0.65, p = 0.23. At 6 months, change in HbA1c in the hybrid versus usual-care arms was - 0.74% vs - 0.49%, p = 0.69. CONCLUSION: There were no statistically significant differences between the hybrid and usual care in glucose self-monitoring adherence or improvements in HbA1C. TRIAL REGISTRATION: This trial is registered with clinicaltrials.gov identifier: NCT03939793.

Do Incentives Crowd Out Motivation? A Feasibility Study of a Community Vector-Control Campaign in Peru.

Incentives are a useful tool in encouraging healthy behavior as part of public health initiatives. However, there remains concern about motivation crowd out-a decline in levels of motivation to undertake a behavior to below baseline levels after incentives have been removed-and few public health studies have assessed for motivation crowd out. Here, we assess the feasibility of identifying motivation crowd out following a lottery to promote participation in a Chagas disease vector control campaign. We look for evidence of crowd out in subsequent participation in the same behavior, a related behavior, and an unrelated behavior. We identified potential motivation crowd out for the same behavior, but not for related behavior or unrelated behaviors after lottery incentives are removed. Despite some limitations, we conclude that motivation crowd out is feasible to assess in large-scale trials of incentives.

A Randomized Trial of Behavioral Nudges Delivered Through Text Messages to Increase Influenza Vaccination Among Patients With an Upcoming Primary Care Visit.

PURPOSE: To evaluate if nudges delivered by text message prior to an upcoming primary care visit can increase influenza vaccination rates. DESIGN: Randomized, controlled trial. SETTING: Two health systems in the Northeastern US between September 2020 and March 2021. SUBJECTS: 74,811 adults. INTERVENTIONS: Patients in the 19 intervention arms received 1-2 text messages in the 3 days preceding their appointment that varied in their format, interactivity, and content. MEASURES: Influenza vaccination. ANALYSIS: Intention-to-treat. RESULTS: Participants had a mean (SD) age of 50.7 (16.2) years; 55.8% (41,771) were female, 70.6% (52,826) were White, and 19.0% (14,222) were Black. Among the interventions, 5 of 19 (26.3%) had a significantly greater vaccination rate than control. On average, the 19 interventions increased vaccination relative to control by 1.8 percentage points or 6.1% (P = .005). The top performing text message described the vaccine to the patient as "reserved for you" and led to a 3.1 percentage point increase (95% CI, 1.3 to 4.9; P < .001) in vaccination relative to control. Three of the top five performing messages described the vaccine as "reserved for you." None of the interventions performed worse than control. CONCLUSIONS: Text messages encouraging vaccination and delivered prior to an upcoming appointment significantly increased influenza vaccination rates and could be a scalable approach to increase vaccination more broadly.

Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).

BACKGROUND: The Diabetes Prevention Program (DPP) and metformin can prevent or delay the onset of type 2 diabetes mellitus (T2DM) among patients with prediabetes. Yet, even when these evidence-based strategies are accessible and affordable, uptake is low. Thus, there is a critical need for effective, scalable, and sustainable approaches to increase uptake and engagement in these interventions. METHODS: In this randomized controlled trial, we will test whether financial incentives and automated messaging to promote autonomous motivation for preventing T2DM can increase DPP participation, metformin use, or both among adults with prediabetes. Participants (n = 380) will be randomized to one of four study arms. Control Arm participants will receive usual care and educational text messages about preventing T2DM. Incentives Arm participants will receive the Control Arm intervention plus financial incentives for DPP participation or metformin use. Tailored Messages Arm participants will receive the Control Arm intervention plus tailored messages promoting autonomous motivation for preventing T2DM. Combined Arm participants will receive the Incentives Arm and Tailored Messages Arm interventions plus messages to increase the personal salience of financial incentives. The primary outcome is change in hemoglobin A1c from baseline to 12 months. Secondary outcomes are change in body weight, DPP participation, and metformin use. DISCUSSION: If effective, these scalable and sustainable approaches to increase patient motivation to prevent T2DM can be deployed by health systems, health plans, and employers to help individuals with prediabetes lower their risk for developing T2DM.